LTC Bulletin Board - May 2012

FDA News

FDA Approves Drug for Use in Brain Imaging in Adults Evaluated for Cognitive Decline

On April 10, 2012, the FDA approved AmyvidTM (florbetapir F 18 injection), a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline.  Following intravenous injection, Amyvid binds to beta-amyloid protein in the brain, a protein shown to form in patients with AD and other cognitive disorders. Amyvid produces a positron signal, which is detected by PET scanners to show the brain density of beta-amyloid neuritic plaque, characterized as abnormal clumps of brain cells mixed with beta-amyloid protein.

“Many Americans undergo evaluations to try to determine the cause for a decline in cognitive functioning,” said Janet Woodcock, MD, director, FDA Center for Drug Evaluation and Research, in a press release. “Until now, the brain content of beta-amyloid neuritic plaques could only be determined with a brain biopsy or examination of the brain at autopsy,” she added. A negative Amyvid scan indicates few to no neuritic plaques, whereas a positive scan indicates moderate to frequent neuritic plaques. A negative scan indicates a low likelihood that a patient’s cognitive impairment is due to AD; however, a positive scan does not necessarily establish a diagnosis of AD or other cognitive disorder, as neuritic plaque can present in patients with other neurological conditions as well as in those with normal cognition. As such, Amyvid is recommended as an adjunct to other diagnostic evaluations, Woodcock said.

The safety and efficacy of Amyvid was evaluated in three clinical studies that examined images from healthy adult patients as well as patients with a range of cognitive disorders, including some terminally ill patients who participated in a postmortem brain donation program. The most commonly observed adverse effects were headache, musculoskeletal pain, fatigue, and nausea. Amyvid is manufactured by Eli Lilly and Company and Avid Radiopharmaceuticals. Learn more about Amyvid’s indications and usage at https://amyvid.com.

FDA Approves Generic Drugs for Treatment of Hypertension

On March 30, 2012, the FDA approved the first generic versions of Avapro® (irbesartan) and Avalide® (irbesartan/hydrochlorothiazide) tablets for the treatment of hypertension, a prevalent condition in the United States, especially in older adults, and a known risk factor of heart disease, stroke, and kidney disease. Irbesartan is an angiotension II receptor antagonist that works by blocking the action of certain natural substances that constrict blood vessels, allowing the heart to pump blood more efficiently. It can be used alone or in combination with other medications to treat hypertension. In clinical trials, when irbesartan was added to hydrochlorothiazide, a diuretic drug, patients experienced further dose-related reductions in blood pressure, similar to those achieved with the same monotherapy dose of irbesartan, according to Avapro prescribing information. Irbesartan is also indicated for the treatment of diabetic nephropathy with elevated serum creatinine levels and proteinuria (>300 mg/day) in patients with type 2 diabetes mellitus and hypertension. Generic drugs approved by the FDA achieve the same quality standards as brand-name drugs. Generic Avapro and Avalide are manufactured by Teva Pharmaceuticals Inc.
 

Medical News

Magnesium Deficiency Increases Risk of Bone and Heart Disease

The National Institutes of Health reports that approximately 70% of older women use dietary supplements containing calcium; however, according to studies by the National Magnesium Association (NMA), consuming too much calcium without balancing its intake with magnesium could cause many adverse health outcomes, including osteoporosis, arthritis, myocardial infarction, and kidney stones. According to Carolyn Dean, MD, ND, of the NMA, women in the United States over the age of 50 years are advised to take up to 1500 mg of calcium daily; however, high-calcium diets are often not properly balanced with magnesium, which facilitates the absorption and metabolism of calcium and vitamin D.

Typically, less than half of each calcium dose is naturally absorbed into the bloodstream, with the remainder being excreted through the kidneys or becoming lodged in other areas of the body. As excess calcium accumulates, it may harden and cause kidney stones or calcification around the arteries, leading to cardiovascular issues. Magnesium increases the solubility of calcium and stimulates the hormone calcitonin, helping to preserve bone structure. A 2:1 or at least a 1:1 ratio of calcium to magnesium is recommended to prevent the harmful effects of magnesium deficiency.

“The high calcium–low magnesium diet of most Americans when coupled with calcium supplementation can give a calcium to magnesium imbalance of 4:1 or 5:1, which constitutes a walking time bomb of impaired bone health and heart disease,” said Dean in a press release.

New Adult Brief Offers Comfort and Dignity in Management of Incontinence

Millions of older adults residing in nursing homes and in the community have urinary incontinence and wear absorbent undergarments to manage episodes of involuntary leakage. Yet adult briefs can often be uncomfortable, leak, and cause odor, skin irritation, and urinary tract infections. Medline, a provider of healthcare supplies to long-term care facilities, recently announced the launch of the FitRight™ brief, which aims to solve many of the problems observed with the use of adult briefs.

“FitRight is designed with the individual’s needs in mind,” said Dan Love, president, Medline Personal Care Division, in a press statement. “It fits better around the legs, absorbs more fluid, and keeps the resident dryer for longer periods of time, which leads to greater comfort, confidence, and dignity.” FitRight briefs promote skin dryness via antileak guards, which wick moisture away from the skin by drawing it into the brief’s core; side panels that promote airflow around the body; and a moisture alert wetness indicator that changes color when the garment has been soiled. For more information about FitRight briefs, visit www.medline.com/pages/fitright, where a staff training video on using the garment in the LTC setting is also available.

Inexpensive Kit Promotes Hygienic Cast Care

Cast immobilization is commonly used in elders with fractures and broken bones. Itching and odor of the skin underneath the cast often occurs in these individuals and can be difficult to manage. Sani-CastTM is a new product designed especially for sanitizing and deodorizing skin wrapped in an orthopedic cast. A Sani-Cast kit includes a 21-inch medical-grade applicator and 36 premoistened disposable cleansing pads. To use, simply attach one of the cleansing pads to the applicator and glide it underneath the cast in an up and down manner.

“All too often a patient will insert an unsanitary household object under their cast to deal with itching caused by bacteria,” said Michael Hogan, vice president, Sani-Cast, in a press release. “Objects such as coat hangers, rulers, and pencils break the skin, causing a series of health complications.” The Sani-Cast kit sells for $15 and can be found at several pharmacies nationwide. To purchase the Sani-Cast kit and to view a demonstration of the product, visit www.sani-cast.com.